The following data is part of a premarket notification filed by Clinical Sciences, Inc. with the FDA for Rapid Plasma Reagin Card Test.
| Device ID | K842541 |
| 510k Number | K842541 |
| Device Name: | RAPID PLASMA REAGIN CARD TEST |
| Classification | Antigens, Nontreponemal, All |
| Applicant | CLINICAL SCIENCES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GMQ |
| CFR Regulation Number | 866.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-02 |
| Decision Date | 1984-07-26 |